Mar 15, 2016
I’m working with a number of clients at present providing quality consultancy in the following areas:
Client 1 The improvement of their Quality Management System as they look to bring in-house the release of their drug – device product.
Client 2: Advice and guidance in relation to the building of a new facility for Advanced Therapeutic Medicinal Products.
Client 3: This client manufactures novel vaccines for early stage clinical trials. I am providing assistance in the following areas:
- updating their Quality Management System;
- assisting with qualification and validation of utilities and computerised systems;
- supplier audits;
- QP certification and release of product to clinical trials.
Client 4: Advice on QP issues related to gene therapy products.
Jan 31, 2013
US FDA Apply for Listing as a Third Country for API Supply
On the17th January 2013, the US FDA has applied to the EU to be listed an a Third Country that has equivalent GMPs to the EU for the manufacture of APIs. The FDA joins the regulatory authorities of Israel, Brazil, Australia, Singapore and Japan seeking this listing. Currently, Switzerland is the only country to have been listed by the EU. Assessment is ongoing with the other countries.
(Posted: 31st January 2013)
New Chapters and Annexes of the EU GMP Guide Come Into Force
Today the the latest version of Chapter 1 – Pharmaceutical Quality Management Systems, Chapter 7 – Outsource Activities and Annex 2 -Manufacture of Biological active substances and Medicinal Product for Human Use came into operation. For the new versions of these chapters and annex go to http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
(Posted 31st January 2013)
Presentation at Clinical Trial Supply Europe Conference
On Friday 1st February 2013, I will be presenting at the Clinical Trial Supply Europe Conference in Basel Switzerland. My presentation will be discussing the reason why Enterprise Resource Planning(ERP) systems are not widely employed in the clinical supply chain.
Apart from my presentation, the rest of the program looks interesting. For further details visit the Clinical Trials Supply Europe website.
http://www.pharma-iq.com/supply-chain-security/articles/clinical-trial-supply-conference-basel-europe-2013/?Mac=PMIQ_PPC_CTS_Basel&gclid=CMvhouDe_LQCFefMtAod_FoAPg
(Posted 21st January 2012)
More MHRA Inspectors Required?
In a recent posting in FDA news, there was a report that the MHRA will require approximately 1200 sites to ensure compliance with the new API rules. The posting also said that the MHRA would clarify is position on these new rules by the end of the year. However, to date I’ve not seen anything on the MHRA website clarifying its position.
In the same post, an expert reckons the FDA would have to conduct up to 2,000 inspections of generic API suppliers, if they decide to comply with the EU requirements.
The question for these agencies is do they have the resource for these inspections and how will this affect other inspection plans?
Industry Concerns on Lack of FDA Policy for Dealing with EU Falsified Medicines Directive
In today’s FDA Drug Bulletin, it is interesting to note that concerns are now being raised in the US by manufacturers about the potential for lost sales and drug shortages in Europe, due to the fact that the FDA has no policy or guidance in place for the new EU requirement for regulatory bodies to verify that APIs have been made in accordance with EU GMP standards.
Is this the start of industry pressure on the regulators to highlight the potential concerns that these requirements have on the supply of many common medicines?
New Rules on Importing Active Pharmaceuticals
From 2nd January 2013, there are new EU rules on the importation of active substances for human medicinal products. From that date there will a requirement to have imported active substances to be manufactured in compliance with EU Good Manufacturing Practice (GMP) standards, which equate to the requirements of ICH Q7A. This means that the same rules will apply for active substances manufactured in the EU an in third countries and is a sensible move to ensure that patient safety is safeguarded.
In addition to the above requirement, as of 2 July 2013, the compliance that the active substance has been manufactured in accordance with GMP needs to be provided by the exporting contry’s competent authority. This compliance must also state the plant where the active substance was manufactured is subject to control and enforcement of GMP standards that are equivalent to those in the EU.
Whilst I do not know the current status of whether there are agreements in place between other competent authorities and the EU, I do know that the FDA have not decided whether they will issue these compliance documents.
Given that a lot of active substances come from third countries, shortages of many common drugs may occur if third country competent authorities do not provide this documentation. I await to see how this new requirement will be implemented.
For more information on this new EU requirement click on the following link:
http://ec.europa.eu/health/human-use/quality/index_en.htm
